A doctor viewing scans


Global MASH Clinical Trial Imaging Operations

  • Offering advanced quantitative imaging biomarkers for metabolic dysfunction-associated steatohepatitis (MASH) (formerly known as non-alcoholic steatohepatitis (NASH))
    • Volumetric measurements for liver and spleen
    • Fat content using MRI and/or MRS proton density fat fraction estimates (MRI-PDFF)
    • Fibrosis/stiffness using MR elastography and/or FibroScan® acoustic elastography
  • Full-service multi-platform imaging core lab (GCP & CFR-Part 11)
  • Global site management

Deep & Broad MASH Imaging Experience

  • Global reach with trials at more than 200 sites in more than 1000 patients
  • Multi-site management and QA for trials with MRE, MRS, MRI and FibroScan® biomarkers for NASH

Maximize Consistency of Image Acquisition within
and across Sites

  • Define and verify scanners, acquisition parameters, anatomical coverage, and scanning protocols
  • Establish procedures for site qualification, routine quality assurance, and quality control
  • Audit trail from enrollment to image upload and verification

Ensure Consistency of Image Review and Analysis

  • Experienced project managers and technologists verify image uploads and quality
  • Qualified, board certified centralized image readers/reviewers

ClinTrak Imaging® – Medpace Clinical Trial Management System

A powerful, proprietary image management software program purpose-built for supporting clinical trials

  • Full integration of CTMS with imaging workflow (industry leader)
  • Team of dedicated in-house developers
  • Secure electronic transfer images/files
  • 21 CFR Part 11 compliant
  • 24/7 site support in various languages
  • Image/scan tracking and archiving
  • De-identification/masking
  • Customized imaging eCRF
  • Data management/query resolution and tracking
  • Integrated image virtualized workstation
  • Real-time web-based status reporting

Related MASH Imaging Insights